Florida Fleet Phospho-Soda Attorneys

PREPARING FOR A COLONOSCOPY CAN POSE DANGER OF KIDNEY FAILURE FROM RECALLED FLEET PHOSPHO-SODA; SEARCY DENNEY ATTORNEYS NOW REPRESENTING VICTIMS

Colorectal cancer - cancer of the colon or rectum - is the second leading cause of cancer deaths in the United States, and one of the most excruciatingly painful cancers. The American Cancer Society estimates that in 2008, 149,000 people developed this horrific disease, and nearly 50,000 of them died.

Here's the good news: The death rate is dropping because of a very effective screening method, a colonoscopy, now recommended for everyone over 50 years of age.

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Prior to a colonoscopy, the patient's bowel must be cleansed thoroughly in order to ensure that the physician performing the procedure can visualize the entire bowel. This bowel preparation process, however, has been documented to cause kidney failure and other potential health problems in unsuspecting patients

The culprit is an over-the-counter and prescription bowel preparation product, oral sodium phosphate (OSP), sold as Visicol, OsmoPrep, and Fleet Phospho-Soda and used by an estimated five million people a year.

After the Food and Drug Administration (FDA) issued a Safety Alert on December 11, 2008, Fleet announced a voluntary recall of its over-the-counter Phospho-Soda and another Fleet product, EZ-Prep Bowel Cleansing System. Manufacturers of the prescription oral sodium phosphate products (Visicol and OsmoPrep) will be required to add a "black box" warning, the strongest warning utilized for FDA-regulated drugs. The FDA has recommended that over-the-counter products no longer be used for bowel cleansing, although these products may continue to be marketed as laxatives.

Phosphate, the primary ingredient in Phospho-Soda and other sodium phosphate products, triggers fluid accumulation in the bowel, which then prompts clearing out of the contents - essential to a successful colonoscopy. Patients are required to drink one and a half ounces of Phospho-Soda with liquids the day before a colonoscopy, and again up to three hours before the procedure. Unless sufficient fluids are ingested the day before, and the morning of, the colonoscopy, dehydration can result.

The Journal of the American Society of Nephrology reported as early as November 2005 that Phospho-Soda may contribute to a specific type of kidney problem called acute phosphate nephropathy. This acute kidney injury is associated with deposits of calcium-phosphate crystals in the renal tubules, which may result in permanent renal function impairment (kidney failure).

The FDA first reported in 2006 the association between acute phosphate nephropathy and oral sodium phosphate products (OSP) such as Fleet Phospho-Soda. The effort to alert the public to these concerns, however, did not occur until December 2008. With new resolve to better inform the public of drug safety issues, the FDA has ordered that manufacturers produce a Medication Guide to provide patients with more information about the safe use of these products.  

Among those most vulnerable to the danger of acute phosphate nephropathy are patients with renal insufficiency, moderate to severe congestive heart failure, cirrhosis, or obstruction of the digestive tract. According to the FDA, risks increase dramatically for people over age 55 and children under five; people with decreased intravascular volume; and those with baseline kidney disease, bowel obstruction, or active colitis. People using medications that affect renal function - such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and possibly nonsteroidal anti-inflammatory drugs - are also at greater risk.

Contact us for more information and a free consultation with an experienced Florida Fleet Phospho-Soda lawyer.

Attorneys at Searcy Denney are now representing clients whose lives have been devastated by medical conditions caused by dangerous pharmaceuticals. If you or a loved one has suffered from kidney failure or another malady after using Phospho-Soda or another sodium phosphate bowel preparation product to prepare for a colonoscopy, please fill out our contact form, or call us to learn more and arrange for a confidential free consultation.

Related Links:

Update: Fleet Recall - Recalled Fleet Phospho-Soda Info

Fleet Phospho-Soda website: FDA Safety Alert and Information for Healthcare Professionals; Fleet Letter to Healthcare Professionals

C.B. Fleet Voluntarily Recalls Its Fleet Phospho-Soda Products After FDA Safety Alert

FDA Letter to Salix re: Label Changes

Labeling for Phospho-Soda

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